Cryptisel 0.5 mg/ml Oral Solution for Calves

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Halofuginone

Available from:

Livisto Int'l S.L.

ATC code:

QP51AX08

INN (International Name):

Halofuginone

Pharmaceutical form:

Oral solution

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cattle

Therapeutic area:

Antiprotozoal

Authorization status:

Authorized

Authorization date:

2020-11-19

Summary of Product characteristics

Revised: March 2022
AN: 02270/2021 & 02271/2021
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Cryptisel 0.5 mg/ml oral solution for calves
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Halofuginone 0.50 mg
Equivalent to 0.6086 mg of Halofuginone lactate
EXCIPIENTS:
Benzoic acid (E 210) 1.00 mg
Tartrazine (E 102) 0.03 mg
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Oral solution.
Clear yellow solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle (newborn calves).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
•
Prevention of diarrhoea due to diagnosed _Cryptosporidium parvum_, in
farms with
history of
cryptosporidiosis.
Administration should start in the first 24 to 48 hours of age.
•
Reduction of diarrhoea due to diagnosed _Cryptosporidium parvum_.
Administration should start within 24 hours after the onset of
diarrhoea.
In both cases, the reduction of oocysts excretion has been
demonstrated.
Revised: March 2022
AN: 02270/2021 & 02271/2021
Page 2 of 6
4.3
CONTRAINDICATIONS
Do not use on an empty stomach.
Do not use in cases of diarrhoea established for more than 24 hours
and in weak
animals.
Do not use in cases of hypersensitivity to the active substance or to
any of the
excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Administer after colostrum feeding, or after milk or milk replacer
feeding only, using
an appropriate device for oral administration. For treatment of
anorexic calves, the
veterinary medicinal product should be administered in half a litre of
an electrolyte
solution. The
animals should receive enough colostrum according to good breeding
practice.
Special precautions to be taken by the person administering the
veterinary medicinal
product to
animals
-
People with known hypersensitivity to the active substance or any of
the
excipients should administer the veterinary medicinal product with
cauti